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QA Specialist Batch Release
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Sap
Projektbeschreibung
ROLE: QA SPECIALIST - BATCH RELEASE
TYPE - INITIALLY 11 MONTH CONTRACT
LOCATION- CARLOW
KEY RESPONSIBILITIES:
- Provide quality oversight and expertise as required for manufacturing operations.
- Review of all manufacturing batch documentation including electronic batch records, Real Time reports, master data.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
- Assist in the proactive evaluation of site compliance against emerging regulatory trends.
- Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
- Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues eg FMEA, Fishbone diagrams, 5 why's etc.; oversee and implement subsequent corrective action through the change management system.
- Review and approval of validation documents, change controls, SOP's for the department
- Leading out of specification investigation
- Working as directed by QA Lead according to Company safety policies, cGMP and cGLP
KEY EXPERIENCE:
- Bachelor Degree or higher preferred; ideally in a related Science discipline
- Experience working within a manufacturing facility (IMB and FDA approved)
- Expertise in Aseptic Assurance and Process Simulations will be an advantage.
- Experience in batch review, electronic batch record would be an advantage.
- Previous use of SAP/Trackwise would be beneficial.
- A proven track record of effectively working with a manufacturing operations team to ensure best practices are implemented and improved.
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to trouble shoot, identify microbiological issues and follow up with corrective actions.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.
TYPE - INITIALLY 11 MONTH CONTRACT
LOCATION- CARLOW
KEY RESPONSIBILITIES:
- Provide quality oversight and expertise as required for manufacturing operations.
- Review of all manufacturing batch documentation including electronic batch records, Real Time reports, master data.
- Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool.
- Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
- Assist in the proactive evaluation of site compliance against emerging regulatory trends.
- Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate.
- Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues eg FMEA, Fishbone diagrams, 5 why's etc.; oversee and implement subsequent corrective action through the change management system.
- Review and approval of validation documents, change controls, SOP's for the department
- Leading out of specification investigation
- Working as directed by QA Lead according to Company safety policies, cGMP and cGLP
KEY EXPERIENCE:
- Bachelor Degree or higher preferred; ideally in a related Science discipline
- Experience working within a manufacturing facility (IMB and FDA approved)
- Expertise in Aseptic Assurance and Process Simulations will be an advantage.
- Experience in batch review, electronic batch record would be an advantage.
- Previous use of SAP/Trackwise would be beneficial.
- A proven track record of effectively working with a manufacturing operations team to ensure best practices are implemented and improved.
- Ability to critically review analytical data. Possessing excellent attention to detail is a must.
- Ability to trouble shoot, identify microbiological issues and follow up with corrective actions.
- Experience of preparing for and participating in regulatory audits in particular IMB/FDA.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung